Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.

The Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, on Physical Conditioning in Women: a Randomized Controlled Trial.

The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: MyPlate; Behavioral: MyPlate + Exercise; Behavioral: Paleolithic; Behavioral: Paleolithic + Exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Clemson, South Carolina, United States, 29631
      • Clemson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• body fat percent between 20 and 38
• less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task
• not pregnant, trying to become pregnant or lactating
• non-smoker
• no previous resistance training
• have not been on a diet in the past three months
• no dietary restrictions (food allergies, disease conditions, etc)
• have not lost more than 10 lbs. in the past three months

Exclusion Criteria:

• taking any medication
• women who have had a left breast mastectomy
• do not meet criteria of PAR-Q

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MyPlate; To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.	Behavioral: MyPlate; To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
Active Comparator: MyPlate + Exercise; To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.	Behavioral: MyPlate + Exercise; To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
Active Comparator: Paleolithic; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.	Behavioral: Paleolithic; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.
Active Comparator: Paleolithic + Exercise; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.	Behavioral: Paleolithic + Exercise; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in aerobic conditioning	Peak oxygen consumption	Baseline and 8 weeks
Change in anaerobic power	Wingate anaerobic threshold	Baseline and 8 weeks
Change in strength	Chest press and leg press estimated one repetition maximum	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resting energy expenditure	24 hour kcal and respiratory quotient	Baseline and 8 weeks
Change in urine	Osmolality	Baseline and 8 weeks
Change in insulin (plasma)	Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in glucagon (plasma)	Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in ghrelin (plasma)	Total and active ghrelin; Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in peptide YY 3-36 (plasma)	Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in adiponectin (plasma)	Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in leptin (plasma)	Radioimmunoprecipitation assay	Baseline and 8 weeks
Change in tumor necrosis factor alpha (plasma)	ELISA	Baseline and 8 weeks
Change in interleukin 6 (plasma)	ELISA	Baseline and 8 weeks
Change in undercarboxylated osteocalcin (plasma)	enzymeimmunoassay	Baseline and 8 weeks
Change in total cholesterol (plasma)	Colorimetric enzyme assay	Baseline and 8 weeks
Change in HDL cholesterol (plasma)	Colorimetric enzyme assay	Baseline and 8 weeks
Change in non-HDL cholesterol (plasma)	Calculated from triacylglycerol, total cholesterol and HDL cholesterol	Baseline and 8 weeks
Change in triacylglycerol (plasma)	Colorimetric enzyme assay	Baseline and 8 weeks
Change in non-esterified fatty acids (plasma)	Colorimetric enzyme assay	Baseline and weeks
Change in glucose (plasma)	Colorimetric enzyme assay	Baseline and 8 weeks
Change in ketones (plasma)	Colorimetric enzyme assay	Baseline and 8 weeks
Change in fat mass	Dual energy x-ray absorptiometry	Baseline and 8 weeks
Change in fat free mass	Dual energy x-ray absorptiometry	Baseline and 8 weeks
Change in bone mass	Dual energy x-ray absorptiometry	Baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in free living activity	Armband activity monitor worn on the upper left arm (METs)	Baseline and 8 weeks
Change in blood pressure	Systolic and diastolic blood pressure	Baseline and 8 weeks
Change in resting heart rate	Beats per minute	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Clemson University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-457